Biologic-treated Patients Research Articles

Histological, But Neither Clinical Nor Endoscopic Activity Predicts the Risk of Colectomy in Patients With Ulcerative Colitis Treated With Biologics.

Biological treatment failure is common in patients with ulcerative colitis (UC), but the predictive value of baseline histological activity is unknown. We aimed to investigate the associations between baseline histological activity and outcomes after biological treatment in patients with UC. Adult biological-naïve patients with UC (n = 150) were followed prospectively during biological treatment. Histological activity was assessed using the Nancy Index and Geboes score. Endoscopic activity was assessed using the Mayo Endoscopic Subscore (MES). Associations with outcomes were assessed in multivariable models. Associations between histological, endoscopic, and biochemical activity were assessed using Spearman's correlation. In biological-treated patients with UC, severe histological activity at baseline was independently associated with colectomy risk during the induction period (Nancy 2 vs 4: odds ratio [OR] 0.18, 95% CI 0.01-0.61, P = 0.024; Nancy 3 vs 4: OR 0.12, 95% CI 0.02-0.63, P = .019; Geboes 3 vs 5: OR 0.06, 95% CI 0.00-0.57, P = .033; Geboes 4 vs 5: OR 0.13, 95% CI 0.01-0.69, P = 0.032) and total follow-up (Nancy 2 vs 4: HR 0.23, 95% CI 0.06-0.98, P = 0.046; Nancy 3 vs 4: HR 0.13, 95% CI 0.04-0.47, P = 0.002; Geboes 4 vs 5: HR 0.28, 95% CI 0.08-0.93, P = 0.038). Meanwhile, baseline MES was not independently associated with colectomy risk. Histological activity was correlated with MES and the levels of C-reactive protein, hemoglobin, and albumin, but not calprotectin. Severe histological activity at baseline as characterized by a higher Nancy Index or Geboes score independently predicted colectomy risk in biological-treated UC patients, whereas MES did not. Thus, histological assessment should be encouraged before initiating biological treatment.

Biologics and Oral Small Molecules Are Not Associated With Increased Major Adverse Cardiovascular Events or Venous Thromboembolism in Inflammatory Bowel Disease.

Biologics and oral small molecules (OSM) effectively treat inflammatory bowel disease (IBD), but some are linked to higher risks of major adverse cardiovascular events (MACE) and venous thromboembolism (VTE). This study evaluates the MACE and VTE risks in IBD patients treated with biologics or OSM. Using the TrinNetX multi-institutional database, we examined MACE and VTE in adult IBD patients on biologics and compared them to IBD patients not on biologics. We also compared IBD patients on OSM to those not on OSM. We performed 1:1 propensity score matching. MACE (myocardial infarction [MI], stroke, and all-cause mortality) and VTE were assessed from 30 days to 3 years after drug prescription. After matching, IBD patients on biologics had reduced risk of MI, stroke, and all-cause mortality at 1 year, compared to those not on biologics (P < .05). No significant difference in VTE was observed (P = .5). At 3 years, biologic-treated patients had lower risks of MI, stroke, all-cause mortality, and VTE (P < .05). Inflammatory bowel disease patients on OSM showed no significant differences in MI, stroke, or VTE at 1 and 3 years, but had lower all-cause mortality (P < .05). In older IBD patients with at least 1 cardiovascular risk factor, OSM usage showed no significant difference in MI, stroke, or VTE risk compared to nonusers; however, all-cause mortality was decreased at 3 years (P < .05). Inflammatory bowel disease patients treated with biologics or OSM were not at increased risk of MACE or VTE. Although further studies and longer follow-up periods are needed to confirm these findings, our results provide reassurance regarding the safety of these medications in IBD.

Pain in Biologic-Treated Rheumatoid Arthritis Patients: The Role of Illness Perception Before and After the COVID-19 Pandemic.

We aimed to assess the role of the COVID-19 pandemic in the association of clinical, physical, and psychological factors with pain in Rheumatoid Arthritis (RA) patients. We included 103 RA patients (81.6% females; mean age 56.1±13.8years). Patients filled out the VAS-pain, GAD-7, PHQ-9, MFI-20, and B-IPQ. Paired sample t-tests, correlations, and multiple regression analyses were used to analyse the data. Our results showed significantly worsened pain in the data collected post-pandemic (p≤0.05). Pre-pandemic, the final regression models showed an association between functional disability (β=0.24; p≤0.05), illness perception (β=0.34; p≤0.05) and pain. In post-pandemic models, significant associations were found between fatigue (β=0.33; p≤0.01) and illness perception (β=0.36; p≤0.01) with pain. Positive illness perception was able to alleviate the associations between fatigue and depression with pain before and after the pandemic. Findings indicate that patients with RA may have been negatively affected by the COVID-19 pandemic given their vulnerability. Even though pharmacological treatment was not interrupted, post-pandemic results showed significantly higher levels of experienced pain. Therefore, in addition to biological therapy, non-pharmacological interventions, including psychological support aimed at diminishing negative illness perception, may be beneficial in reducing RA-related pain, especially when dealing with a crisis.

Impact of gluten intake on clinical outcomes in patients with chronic inflammatory diseases initiating biologics: Secondary analysis of the prospective multicentre BELIEVE cohort study.

Chronic inflammatory diseases (CIDs) pose a growing healthcare challenge, with a substantial proportion of patients showing inadequate response to biological treatment. There is renewed interest in dietary changes to optimize treatment regimens, with a growing body of evidence suggesting beneficial effects with adherence to a gluten-free diet. This study compared the likelihood of achieving clinical response to biological treatment after 14-16 weeks in patients with CID with high versus low-to-medium gluten intake. Secondary outcomes of interest included changes in disease activity, health-related quality of life and C-reactive protein. The study was a multicentre prospective cohort of 193 participants with a CID diagnosis (i.e. Crohn's Disease, Ulcerative Colitis, Rheumatoid Arthritis, Axial Spondyloarthritis, Psoriatic Arthritis or Psoriasis) who initiated biological treatment between 2017 and 2020. Participants were stratified based on their habitual gluten intake: the upper 33.3% (high gluten intake) and the remaining 66.6% (low-to-medium gluten intake). The proportion of patients achieving clinical response to biological treatment after 14-16 weeks was compared using logistic regression models. The median gluten intake differed significantly between groups (12.5 g/day vs. 5.9 g/day, standardized mean difference = 1.399). In total, 108 (56%) achieved clinical response to treatment, with no difference between 35 (55%) in the high gluten group and 73 (57%) in the medium-to-low gluten group (OR = 0.96 [0.51-1.79], p = 0.897). No differences were found with secondary outcomes. In conclusion, this study found no association between gluten intake and response to biological treatment in patients with CID.

Evaluation of adverse clinical outcomes in patients with inflammatory bowel disease receiving different sequences of first- and second-line biologic treatments: findings from ROTARY

BackgroundPatients with inflammatory bowel disease (IBD) are at risk of developing dysplasia and, subsequently, colorectal cancer (CRC) owing to chronic inflammation. Patients may also experience other severe disease complications, such as hospitalization and surgery. Several biologics are available for the treatment of patients with IBD and some patients require multiple lines of treatment owing to loss of response or tolerability to their prescribed biologic. Previous studies suggest that the choice of initial biologic treatment may impact the outcomes of later treatment lines. In this study, we assessed adverse clinical outcomes in patients with Crohn’s disease (CD) or ulcerative colitis (UC) who received different biologic treatment sequences.MethodsROTARY part B was a retrospective cohort study using the Optum® Clinical Database that evaluated the incidences of IBD-related hospitalization, IBD-related surgery, dysplasia, CRC, and infections in patients with CD or UC who received two biologics successively. First-line biologics included adalimumab, infliximab, ustekinumab (CD only), and vedolizumab; second-line biologics included infliximab and adalimumab.ResultsIn patients with CD, the treatment sequence of ustekinumab to infliximab was associated with the highest overall incidences of hospitalization (51.9%), surgery (40.7%), CRC (3.7%), and infection (37.0%). Vedolizumab followed by an anti-tumor necrosis factor alpha (anti-TNFα) treatment was associated with a significantly lower risk of experiencing an adverse medical event (hospitalization, surgery, or infection) than two successive anti-TNFα treatments (odds ratio, 1.526; 95% confidence interval, 1.004–2.320; P < 0.05). In patients with UC, the treatment sequence of vedolizumab to adalimumab resulted in the lowest overall incidence of adverse outcomes (20.3%, 6.3%, 0.0%, 6.3%, and 4.7% for hospitalization, surgery, CRC, dysplasia, and infection, respectively).ConclusionsWe describe differences in adverse clinical outcomes associated with sequencing of biologics in patients with CD or UC and demonstrate favorable results in patients who received vedolizumab as a first-line biologic. These results provide potential guidance to clinicians choosing sequences of biologic treatments in patients with IBD.

Limited predictive value of the gut microbiome and metabolome for response to biological therapy in inflammatory bowel disease

ABSTRACT Emerging evidence suggests the gut microbiome’s potential in predicting response to biologic treatments in patients with inflammatory bowel disease (IBD). In this prospective study, we aimed to predict treatment response to vedolizumab and ustekinumab, integrating clinical data, gut microbiome profiles based on metagenomic sequencing, and untargeted fecal metabolomics. We aimed to identify predictive biomarkers and attempted to replicate microbiome-based signals from previous studies. We found that the predictive utility of the gut microbiome and fecal metabolites for treatment response was marginal compared to clinical features alone. Testing our identified microbial ratios in an external cohort reinforced the lack of predictive power of the microbiome. Additionally, we could not confirm previously published predictive signals observed in similar sized cohorts. Overall, these findings highlight the importance of external validation and larger sample sizes, to better understand the microbiome’s impact on therapy outcomes in the setting of biologicals in IBD before potential clinical implementation.

Descriptive observational study on the use of virtual reality in patients with inflammatory bowel disease undergoing biological treatment

BackgroundVirtual reality (VR) is a neurosensory experience in which simulated spaces a person has the sensation of being able to function within them. Some patients with inflammatory bowel disease (IBD) receive intravenous biological treatments in an Adult Day Hospital (ADH) regime. VR has been used in some fields of medicine, demonstrating its usefulness in reducing negative symptoms. However, we do not have any literature showing the applicability in real clinical practice of VR in IBD. MethodsDescriptive observational pilot study based on an initial cohort of 87 patients that were obtained from the ADH of the IBD Unit. Satisfaction and acceptance of VR through the use of 3D glasses and the reduction of negative symptoms during intravenous biological treatment in patients with IBD in ADH have been assessed. Results43 patients (52.4%) used VR and completed the study. In the comparative analysis of the results of the questionnaires before and after the use of VR, a statistically significant improvement was observed in the patients’ view on the ability of VR to achieve a reduction in stress (65% patients improve; p: 0.0021) and pain (VAS, 54% p. improve; p<0.05) during treatment. Likewise, with the applicability of VR in other areas of medicine (53%; p: 0.05) and with the possibility of improving well-being during the stay in the ADH (56%; p: 0.0014). No side effects were reported with the use of the 3D glasses. ConclusionsVR is a useful complementary tool to improve the stay of patients with IBD on ADH during intravenous treatment.

A single-center, retrospective study of treatment adherence for biological treatment in patients with psoriasis

A single-center, retrospective study of treatment adherence for biological treatment in patients with psoriasis

Evaluation of multiple-flows exhaled nitric oxide and its clinical significance in severe asthmatic patients treated with biologics: a prospective real-life study

Background Specific biomarkers, such as eosinophilia in peripheral blood or fractional exhaled nitric oxide (FeNO), can guide us in the choice of biologic therapy, allowing a more personalized approach. Although there are multiple evidences in the literature about the role of FeNO as a predictor of response to different biologic treatments, there are no data on the relationship between FeNO changes and clinical response to the four biologic drugs currently in use. Objective To evaluate and to compare the expression of multiple-flows FeNO parameters in a cohort of patients with severe asthma (SA) before and during the treatment with biologics to evaluate the performance of these biomarkers in predicting the achievement of clinical remission. Methods We prospectively enrolled 50 patients with severe asthma eligible for biologic therapy. Patients underwent clinical and functional monitoring at baseline (T0) and after 1, 6, and 12 months of treatment (T1, T6, T12), including multiple flows FeNO assessment. Results A statistically significant reduction of FeNO50 values and J’awNO was observed only in benralizumab and dupilumab subgroups. Among biomarkers, the reduction of FeNO 50 values at T1 was associated with a higher probability of achieving clinical remission at T12 (p = 0.003), which was also confirmed by ROC curve analysis (AUC 0.758, p = 0.002; sensitivity 60% and specificity 74% for a reduction of 16 ppb). Conclusion These data confirm the potential of this biomarker in predicting clinical response to biologic treatment in patients with severe asthma in order to guide clinical decisions and evaluate a shift to other biologic therapy.

Treatment of psoriasis with different classes of biologics reduces the likelihood of peripheral and axial psoriatic arthritis development.

To assess the potential role of biological treatment for psoriasis (PsO) in reducing the likelihood of psoriatic arthritis (PsA), through a detailed analysis that considered the different historical phases in the PsA management, the different biologics classes, and the different patterns of articular involvement. A monocentric cohort of 1023 PsO patients underwent a rheumatologic assessment in which clinical and therapeutic data were recorded. Chi-squared test and multivariate logistic regression analysis (adjusted for the main PsA risk factors) were performed to compare the likelihood of PsA development in different treatment groups. The PsA prevalence in PsO patients treated at least once with biologics was significantly lower than in patients never treated with biologics (8.9% vs 26.1%, p< 0.001). In multivariate analysis, a significantly (p< 0.01) lower likelihood of PsA development in biologic-treated patients was confirmed in the whole cohort (adjOR 0.228), as well as in the subgroups of patients with PsO onset after 2005 (adjOR 0.264) and after 2014 (adjOR 0.179). Separately analysing the different biologics classes, both the TNF (adjOR 0.206), IL-17 (adjOR 0.051) and IL-23 or 12/23 (adjOR 0.167) inhibitors were significantly (p< 0.01) associated with a lower likelihood of PsA development. Finally, patients treated with biologics had a significantly (p< 0.04) lower prevalence of both pure peripheral PsA (adjOR 0.182) and peripheral PsA with axial involvement (adjOR 0.115). This study provides meaningful and concordant evidence supporting the significant role of different classes of biologics in reducing the likelihood of peripheral and axial PsA development.

Drug Persistence and Incidence of Active Tuberculosis of Tumor Necrosis Factor Alpha Inhibitors Versus Tocilizumab as the First-Line Biological Treatment in Patients with Rheumatoid Arthritis: A Nationwide Population-Based Retrospective Cohort Analysis.

Drug persistence may be a surrogate marker that reflects both long-term efficacy and safety in clinical settings, and tuberculosis (TB) is considered as one of the most important opportunistic infections after the biological treatment in rheumatoid arthritis (RA). We aimed to compare drug persistence and incidence of TB between tumor necrosis factor alpha (TNFα) inhibitors and tocilizumab in patients with RA using data from the Korean Health Insurance Review and Assessment Service database. In this analysis, 5449 patients with RA who started TNFα inhibitors, such as adalimumab, etanercept, infliximab, and golimumab or tocilizumab, as the first-line biological therapy between January 2014 and December 2017 were analyzed and followed up until December 2019. Drug persistence was defined as the duration from initiation to first discontinuation, and TB was defined as the prescription of > 2 anti-TB medications after the initiation of biologics. TNFα inhibitors and tocilizumab were prescribed in 4202 (adalimumab, 1413; etanercept, 1100; infliximab, 769; golimumab 920) and 1247 patients with RA, respectively. During the analysis period, 2090 (49.7%) and 477 (38.3%) patients with RA discontinued TNFα inhibitors and tocilizumab, respectively, and 42 patients with RA developed TB (TNFα inhibitors, 33; tocilizumab, 9). After adjustment for confounding factors, TNFα inhibitors were significantly associated with a higher risk of discontinuation compared with tocilizumab (hazard ratio (HR) 1.63, p < 0.001). In subgroup analysis, all types of TNFα inhibitors, except for infliximab, demonstrated a significantly lower persistence rate compared with tocilizumab. There was no significant difference in TB incidence between tocilizumab and TNFα inhibitors. In subgroup analysis, infliximab has a significantly higher risk of TB compared with tocilizumab (HR2.84, p = 0.02). In this analysis, tocilizumab had longer persistence than TNFα inhibitors with a similar incidence of TB. Our analysis has limitations: (1) The HIRA database lacks clinical details like disease activity and joint damage extent, potentially influencing the analysis results. (2) Reasons for discontinuing biological agents were not available. (3) TB diagnoses may be inaccurate because of missing microbiological results. (4) We did not analyze the impact of treating latent TB infection on TB development post-biological treatment, despite mandatory screening in Korea.

Dose escalation of biologic treatment in patients with moderate-to-severe psoriasis in Japan.

Patients receiving interleukin (IL)-inhibiting biologics for moderate-to-severe psoriasis (PsO) may be treated with escalated doses to optimize outcomes. This study evaluated escalation prevalence in a Japanese claims analysis of patients with PsO diagnosis preceding IL-inhibiting biologic treatment and ≥1 post-induction maintenance claim (index date) with sufficient data availability from January 2014 to May 2022. Patients with non-persistence were excluded. Expected daily dose (EDD) was calculated as the recommended maintenance dose divided by the treatment interval. Dose escalation was defined as ≥2 claims showing a ≥20% increase in the observed average daily dose (ADD) over the EDD (with sensitivities requiring ≥1 claim and ≥30%). Significant differences were tested using multivariable regressions. The study included 982 unique patients treated with brodalumab (BRO; n = 104), guselkumab (GUS; n = 207), ixekizumab (IXE; n = 159), risankizumab (RIS; n = 135), secukinumab (SEC; n = 215) and ustekinumab (UST; n = 196). Within 12 months, dose escalation was observed for all IL-inhibiting biologics other than GUS and RIS: 44.4% for UST, 37.2% for IXE, 3.4% for SEC and 1.4% for BRO. In multivariable-adjusted analyses, odds of dose escalation were significantly lower for all products relative to UST. In sensitivities, escalation was observed for all products except RIS.

Impact of Obesity and Lung Function on the Efficacy of Biological Treatment in Patients With Asthma.

Impact of Obesity and Lung Function on the Efficacy of Biological Treatment in Patients With Asthma.

Beyond diagnosis: investigating hospital referral impact on biological treatment initiation, hospital admission, and surgery patterns in inflammatory bowel disease – a Danish population based study

Objectives Early biological treatment in patients with inflammatory bowel disease (IBD) is important in disease control. Previous studies have suggested that patients with IBD from Non-Academic Hospitals were less likely to receive biologics. The aims of this study were (1) to use the granular data in the clinical database, GASTROBIO, to study detailed differences in time from IBD diagnosis to first administration of biologics, hospital admission, and surgery in patients referred to Academic Hospitals versus to Non-Academic Hospitals, and (2) to explore differences in disease extent, behavior, and indication for biological treatment. Material and methods This was a retrospective cross-sectional descriptive population-based quality study of patients with IBD initiating biologics in the North Denmark Region between 2016 and 2018. Data from GASTROBIO were extracted, namely demographic data, time of diagnosis, biological treatments with indications, hospital admission, and surgery. Results Of the 146 patients included, 84 were from the Academic and 62 from the Non-Academic Hospitals. No significant differences in median time from diagnosis to (1) treatment, (2) hospital admission or (3) IBD surgery between the groups were observed. A higher percentage of patients with luminal Crohn’s disease were treated with biologics at the Academic Hospital (78% and 66%). Conclusions Based on the findings of this population-based study, we found no evidence that the referral area had a significant impact on the duration from diagnosis to the initiation of biological treatment, hospital admissions, or surgery. However, the data suggested that fewer patients with luminal Crohn’s disease were referred to biologics from Non-Academic Hospitals.

Biological treatment in elderly and young patients with ankylosing spondylitis: TURKBIO real-life data results.

This study aims to investigate the effect of age on disease activity and biological treatment in patients with ankylosing spondylitis (AS). A total of 811 AS patients registered in the TURKBIO registry database between 2011 and 2019 were categorized according to their age at the time of entry into the registry and assigned to one of two groups: young patients, defined as <60 years of age (n=610), and those aged ≥60 years (n=201) were recorded as elderly patients. Demographic, clinical, and laboratory characteristics, along with disease activity markers and other follow-up parameters, as well as current and prior treatments, were electronically recorded during each visit using open-source software. The mean age of the elderly patients was 67±5.8 years, while the mean age of the younger patients was 49.2±10.9 years. Male predominance was lower in the older AS group compared to the younger AS group (p=0.002). During follow-up period, 397 patients (comprising 318 young and 79 elderly individuals) had a history of using at least one biological disease-modifying agent (bDMARD). There was no significant difference between the groups in terms of DMARD and bDMARD-use distributions. First tumor necrosis factor inhibitor (TNFi) retention rates were found to be similar in both groups over 10 years of follow-up. Adverse events were found to be similar in young (19.9%) and elderly (26.8%) AS patients. Research in the TURKBIO cohort reveals that both older and younger patients with AS exhibited similar disease activity levels with comparable treatment approaches. Moreover, the results of TNFi treatments in elderly patients were the same as those observed in younger patients, with no notable increase in safety concerns.

Natural Autoantibodies in Biologic-Treated Rheumatoid Arthritis and Ankylosing Spondylitis Patients: Associations with Vascular Pathophysiology.

Cardiovascular (CV) morbidity and mortality have been associated with rheumatoid arthritis (RA) and ankylosing spondylitis (AS). Natural autoantibodies (nAAb) are involved in innate immunity, as well as autoimmunity, inflammation, and atherosclerosis. There have not been any studies assessing the effects of biologics on nAAbs in RA and AS, also in relation to vascular pathophysiology. Fifty-three anti-TNF-treated RA and AS patients were included in a 12-month follow-up study. Anti-citrate synthase (CS) and anti-topoisomerase I fragment 4 (TOPO-F4) IgM and IgG levels were determined by ELISA. Ultrasonography was performed to assess brachial artery flow-mediated vasodilation (FMD), common carotid intima-media thickness (ccIMT), and arterial pulse-wave velocity (PWV). Other variables were also evaluated at baseline and 6 and 12 months after treatment initiation. Anti-TNF therapy improved FMD in RA and PWV in AS and stabilized ccIMT. TNF inhibition increased anti-CS IgM and IgG, and possibly also anti-TOPO-F4 IgG levels. Various correlation analyses revealed that nAAbs might be independently involved in autoimmunity as well as changes in inflammation and vascular pathology over time in biologic-treated patients (p < 0.05). We also found associations between anti-TOPO-F4 IgG and anti-Hsp60 IgG (p < 0.05). Baseline nAAb levels or nAAb level changes might determine changes in CRP, disease activity, FMD, PWV, and ccIMT over time (p < 0.05). The interplay between arthritis and inflammatory atherosclerosis, as well as the effects of anti-TNF biologics on these pathologies, might independently involve nAAbs.

P785 Obesity in the response to biological treatments in Inflammatory Bowel Disease patients

Abstract Background Obesity rates in patients with IBD reach up to 40%. Several authors suggest that obese patients have worse response rates to treatments. The aim of the study is to determine whether body mass index (BMI) influences the response to biological therapies in IBD. Secondly, other risk factors will be analyzed, and response rates to different biological treatments will be compared. Methods A retrospective cohort study of patients with IBD on biologic drugs under treatment between February 2013 and September 2022 is presented. Patients were recruited from IBD consultation of a tertiary center (Hospital Rey Juan Carlos, Madrid). Inclusion criteria included being under biologic treatment due to IBD and being näive to these therapies. The follow-up of these patients were carried out from February 2013 to September 2022. The main objective of the study is to determine if BMI influences the response to biological treatment in patients with IBD. As secondary objectives we will try to find the existence of other risk factors for loss of response and between different treatments. Treatment failure was defined as: need of dose increase, switch or swap to another biological treatment, clinical deterioration (measured by clinical indexes), use of systemic corticosteroid therapy, hospitalization, endoscopic inflammatory activity or surgical complications. The percentage loss of response was estimated using Kaplan-Meier curves, and factors influencing long-term response were studied using Cox regression. Results A total of 135 patients were included in the study, (mean age of 46.3 years), 59.3% male, 25.9% smokers, with a mean BMI of 26.1 kg/m2 (18.5% with BMI&amp;gt;30 kg/m2). In the study, 60% received infliximab and 45.9% received combined immunosuppressive therapy. Treatment failure was 59.1% in the non-obese and 80% in the obese (p=0.051). There were no differences in long-term response rates according to biologic treatments or disease subtypes. The only predictor factor for long-term response was combined treatment with immunosuppressants (p=0.037). Conclusion Obesity is not associated with a higher treatment failure rate in patients with IBD undergoing biological therapy. Combined treatment with immunosuppressants acts as a long-term response factor.

P559 Descriptive observational pilot study about the use of Virtual Reality (VR) in patients with Inflammatory Bowel Disease (IBD) and biological treatment

Abstract Background Virtual reality (VR) is a neurosensory experience in which simulated images and spaces are created where a person has the sensation of being and being able to function within them. A high percentage of patients with Inflammatory Bowel Disease (IBD) receive intravenous biological treatments in a day hospital (HDD) regime. VR has been used in some fields of medicine, such as Oncology, demonstrating its usefulness in reducing chronic symptoms such as pain or anxiety. However, we don’t have any literature demonstrating the applicability of VR in IBD. Methods Descriptive observational pilot study based on an initial cohort of 87 patients obtained from the HDD of the IBD Unit. Satisfaction and acceptance of VR through the use of 3D glasses and the reduction of negative symptoms during intravenous biological treatment in patients with IBD in HDD have been assessed. Results 43 patients (52.4%) used VR and completed the study. The mean age was 45.3 years. The validated IBDQ-32 questionnaire on quality of life in IBD obtained a mean score of 169 points (range: 32-224). In the comparative analysis of the results of the questionnaires before and after the use of VR, a statistically significant improvement was observed in the patients' view of the ability of VR to achieve a reduction in stress (65% patients improve; p: 0.0021) and pain (VAS, 54% p. improve; p&amp;lt;0.05) during treatment. Likewise, with the applicability of VR in other areas of medicine (53%; p: 0.05) and with the possibility of improving well-being during the stay in the HDD (56%; p: 0.0014). No side effects were reported with the use of the 3D glasses. Conclusion The use of VR could be a useful complementary tool to improve the stay of patients with IBD on HDD during treatment with intravenous biologic drugs. To this end, we believe it is appropriate to complete our research and obtain more data through other studies along the same lines.

Bimekizumab Efficacy by Prior Biologic Treatment in Patients with Moderate to Severe Hidradenitis Suppurativa: 48-Week Pooled Data from the Randomized, Double-Blind, Placebo-Controlled, Multicenter BE HEARD I and II Phase 3 Trials

Bimekizumab Efficacy by Prior Biologic Treatment in Patients with Moderate to Severe Hidradenitis Suppurativa: 48-Week Pooled Data from the Randomized, Double-Blind, Placebo-Controlled, Multicenter BE HEARD I and II Phase 3 Trials

Association between several immune response-related genes and the effectiveness of biological treatments in patients with moderate-to-severe psoriasis.

Biological therapies are safer and more effective against psoriasis than conventional treatments. Even so, 30-50% of psoriatic patients show an inadequate response, which is associated with individual genetic heterogeneity. Pharmacogenetic studies have identified several single nucleotide polymorphisms (SNPs) as possible predictive and prognostic biomarkers for psoriasis treatment response. The objective of this study was to determine the link between several SNPs and the clinical response to biological therapies in patients with moderate-severe psoriasis. A set of 21 SNPs related to psoriasis and/or other immunological diseases were selected and analysed from salivary samples of patients (n = 88). Treatment effectiveness and patient improvement was assessed clinically through Relative Psoriasis Area and Severity Index (PASI), also called 'PASI response', as well as absolute PASI. Associations between SNPs and PASI factors were assessed at 3 and 12 months for every treatment category of IL-17, IL-23, IL-12&23 and TNF-α inhibitors. Multivariate correlation analysis and Fisher's exact test were used to analyse the relationship between SNPs and therapy outcomes. Several SNPs located in the TLR2, TLR5, TIRAP, HLA-C, IL12B, SLC12A8, TNFAIP3 and PGLYRP4 genes demonstrated association with increased short and long-term therapy-effectiveness rates. Most patients achieved values of PASI response ≥75 or absolute PASI<1, regardless of the biological treatment administered. In conclusion, we demonstrate a relationship between different SNPs and both short- and especially long-term effectiveness of biological treatment in terms of PASI. These polymorphisms may be used as predictive markers of treatment response in patients with moderate-to-severe psoriasis, providing personalized treatment.